PLatforms and applications

Genomic & Molecular Services

MOgene can match your sequencing needs with the right equipment, and has built-in redundancy for best-practice job scheduling. We get your data to you faster. Whether you need the 10K+ read lengths of our PacBio Sequel system, or high-throughput production from our Illumina systems, we’ve got the coverage you need.

From whole genome expression studies to low density arrays or qPCR analysis of a small subset of genes, MOGene offers the complete range of Agilent microarrays. We work with clients to design the most effective transcript profiling experiments, selecting arrays best suited to their research goals as well as determining the number and types of replicates to use and selecting the most powerful data analysis method.

MOgene offers Concierge-level scientific and project management services from Technical Consultation, Sample Management  through data delivery

Experience the MOgene(color) Difference

Illumina Sequencing

  • MiSEQ and NextSEQ
  • Offering a wide range of applications
  • Some of the typical applications –
    • Targeted Resequencing
    • Amplicon Sequencing
    • Metagenomics
    • De novo Sequencing
    •  Whole genome sequencing
    • RNA sequencing
    • Small RNA Sequencing

PacBio Sequencing

  • Sequel System
  • Sample-type agnostic wide rage of applications 
  • Some of the typical applications –
    • De novo assembly
    • Exomes and Whole Genomes
    • Targeted Sequencing
    • Base Modifications
    • Isoform Sequencing
    • Amplicon\COSMID Sequencing

NanoString Assays

  • nCounter Sprint Profiler
  • A simple and cost effective solution for multiplex analysis.
  • Wide range of discovery and translational applications. 
  • Typical applications –
    • Gene Expression
    • CNV
    • Protein expression
    • Simultaneous analyses of DNA, RNA and proteins.

 

 

Real Time PCR

  • QuantStudio 12k Flex OpenArray System
  • Bio-Rad ddPCR System
  • Most sensitive and quantitative platform for gene expression.
  • OpenArray system provides high-throughput gene expression as well as genotyping assays

Microarrays

  • We offer, as a Certified Aglient Service Provider, number 1 solution for your microarray needs.
  • High-throughput array processing for any type of project.
  • Typical applications –
    • Gene Expression 
    • CNV
    • Genotyping
    • Methylation
    • ChiP on ChiP

Biologics Testing

MOgene provides custom testing to support clients throughout the biologics product development cycle, from discovery through pre-clinical and clinical studies. (improve on technical content) We start with your testing goals in mind, then offer flexible, adaptable development options that are tailored to your specific needs.

Biologics Discovery Testing

  • Complete cycle of services including Feasibility, Method Development,Qualification & Validation

  • Product characterization,Stability & QC testing of API, in-process samples and finished products

  • Stability & Integrity check of insertion sequence of your protein/biologic(s)

  • Allelic Discrimination assays

Viral Seed and Shedding Testing
  • sVirus shedding and transmission assessment of viral vectors/gene therapy products 
  • Sequencing & genetic stability of viral/vaccine stocks
  • Customized Assays for Detection & Quantitation of virus in Clinical samples
  • Extensive characterization of the MVS including its sequence and analysis of viral subpopulations 
  • Release testing for clinical trial material and commercial product
Cell Line Development & Cell Bank Testing

MOgene’s offers confidence, experience and flexibility with your Cell Line Development (CLD) products. The full suite of services for cell line characterization includes:

          • Characterization of novel cell lines used in production process (e.g., vaccines)
          • Full genome sequencing, Cell identification (STR), Genetic drift studies
          • Quantitation of contaminating Host Cell DNA in the Drug/  Product
          • Determination of Transgene copy number to measure stability in cell lines (e.g CHO) used in recombinant protein production
          • High throughput nucleic extraction and aliquoting pipeline for biobanking purposes
Adventitious Agent Testing
  • Biologics safety testing: ensure cell banks, virus banks, raw materials of animal origin, bulk harvest and clinical batches are free of bacteria, fungi, yeasts, mycoplasma, adventitious viruses and any other potential contaminants.

  • Identification of pathogens from samples (using NGS or qPCR) such as: Vaccine & Virus Stocks, Eukaryote Cell Banks, Prokaryote Cell Banks, API & Raw Material, Investigational materials

Identification of pathogens from samples (using NGS or qPCR) such as:

  • Vaccine & Virus Stocks
  • Eukaryote Cell Banks
  • Prokaryote Cell Banks
  • API & Raw Material
  • Investigational materials

Gene Therapy

MOgene leads in gene expression, translation and utilizing genotyping technology to accelerate pharmaceutical breakthroughs. We have years of expertise in advancing your gene and cell therapy research utilizing precision technology and custom-built quantitation methods.

Biodistribution DNA Testing

MOgene offers comprehensive biodistribution studies to determine the distribution of a gene therapy vector in tissues/ target sites. We support regulatory and scientific aspects of your project by providing information on the safety of the vector, the gene it transports and the expression of the specific transgene.

          • Viral vaccine efficacy  and Viral clearance infectivity studies
          • Detection or quantification of DNA or RNA viruses in cell banks and bulk harvest material
          • Biodistribution analysis by Q-PCR to assess the viral copy number or target sequence in tissues of tested animals/ samples.
          • Custom-designed real-time PCR assays for assessing the safety and efficacy of Nucleic acid Therapeutics
          • Qualification assays prior to  Quantitation to assess test article interference with assay performance.
CART & Other Cell Therapy Testing
  • Chimeric antigen receptor-redirected T cells (CAR-T cells) have become a promising tool in the treatment of hematopoietic malignancies as well as solid tumors. CAR T-cell therapy involves the collection and genetic modification of T-cells in order to introduce a new gene that allows the CAR T-cells to target and kill the patient’s cancer cells. The genetically engineered cells are then infused back into the patient where they begin their work to target and kill the cancer. In addition, gene and cell therapy technologies promise to treat a wide variety of diseases, such as cancer, hemophilia and cystic fibrosis. 
          • Preclinical Biodistribution Studies 
            • MOgene offers GLP complaint qPCR, ddPCR and NGS amplicon sequencing services to accurately assess the quantity of therapeutic cells for biodistribution studies
          • Testing of RNA Samples
            • The team at MOgene has deep experience in qPCR and ddPCR assay design and validation studies in both animal and human samples.
          • Copy Number for Manufactured CAR-T Cells
            • MOgene can help design and validate your qPCR copy number assays and analysis projects complying with cGMP regulations.
          • Replication Competent Lentivirus Assay for CAR-T Cells
            • MOgene offers fast turn-around replication competent lentivirus testing services using qPCR and ddPCR methods.
          • Integration Site Analysis
            • The MOgene team can support the design and customize your assays to determine the gene insertion site. We utilize a combination of technologies to delineate and validate potential insertion junctions and locations in the host genome.
    CRISPR-Edited Gene Testing
    • Since its debut in 2012, CRISPR gene editing has held the promise of curing most of the over 6,000 known genetic diseases. Now it’s being put to the test, and MOgene can help you design and implement solutions for you that live up to this promise.

     

            • Achieve a  better understanding of your Gene editing biological systems
            • Sequencing of the plasmids for rapid and high-confidence verification of the CRISPR delivery vectors
            • Confirm CRISPR-induced knockouts
            • On-target/Off-Target Sequencing after the Gene Editing Event
            • Analyze gene expression via interference (CRISPRi) or activation (CRISPRa)
            • Whole-genome sequencing (WGS) to discover off-target sites 
            • Detection of off-target cleavage sites for cell-based assays (in live or fixed cells) as well in vitro assays
            • Functional analysis of Genome edits by RNA sequencing, Methylation sequencing or ChiP-sequencing
            • Screen cell populations after CRISPR modification to determine the gene-regulatory impact of multiple genes
    Clinical Trial Genomic Testing

    Mogene offers gene expression services ranging from single target to whole transcriptome analysis, quantitative PCR, NexGen sequencing as well as microarrays.

     Custom assay design, validation and transfer for Clinical trial support studies

            • SNP genotyping
            • Determine the genetic stability of recombinant products and characterization of  plasmid products by Copy number determination and DNA/RNA/plasmid sequencing 
            • Targeted gene sequencing panels for various therapeutic applications
            • Microarrays for gene expression and genotyping

    Quality and safety

    The Quality Commitment From MOgene

    Operations -QMS

    MOgene, a CLIA certified facility, has an established reputation of complying with relevant national and international GxP compliance regulations.  

    • CLIA Regulations 42 CFR Part 493, cGMP compliance per FDA 21 CFR Part 210/211, GLP compliance per FDA 21 CFR Part 58 and Part 11.
    • Complete documentation of laboratory procedures SOPs, 100% QC of data,CAPA program.
    • Audit ready for Clients with routine internal quality audits 
    • Rigorous Sample Management process.
    • Assays validated per ICH/CLSI guidelines
    • Optimized unidirectional workflow laboratory for cross-contamination prevention
    • Transparent and routine communications on project timelines and deliverables
    Integrated Quality

    MOgene has a robust Quality Management System(QMS) detailed in a Quality Manual that details the quality policy of MOgene along with a set of quality procedures that outline the necessary documented controls and compliance measures to ensure continual quality monitoring and improvement.”

    BioSafety
    • Dedicated BSL2 and PreAmp room for your Clinical and Genomics projects
    • UNIDIRECTIONAL flow of work from Sample prep Room to Preamplification Room to Instrument.
    • Trained Personnel to handle all kinds of BSL2 level agents/Samples
    • Support studies that need higher levels of lab safety e.g antimicrobial, human and animal health vaccine development.
    Security and Data Protection
    • Individually coded Key access to Labs
    •  24/7/365 Temperature and Humidity Monitoring
    • Data-Daily Back-up

    Platforms

    [gs_logo theme="slider1" logo_color="gray_to_def" title="no" tooltip="" logo_cat="clients,projects,portfolio"]

    CONTACT MOGENE

    To contact MOgene, please fill out the form. If you are ready to requeast a quote you can go to our Quotations page with a more detailed form to submit your request and company information

    Quote Request

    Contact Us